A cell bank is a collection of cells obtained from pooled cells or derived from a single cell clone or donor tissue that is stored
in bags or vials under defined conditions that maintain genotypic and phenotypic stability. The cell bank system usually consists of a master cell bank (MCB) and a working cell bank (WCB), although alternative approaches are possible. The MCB is produced in accordance with cGMP and preferably is obtained from a qualified source with known and documented history. Human cells and tissues should be obtained by means of a licensed tissue acquisition vendor with a donor qualification program in accordance to 21 CFR 1271. The WCB is produced or derived by expanding one or more vials of the MCB. The WCB or MCB becomes the source of cells for every batch produced for human use. Cell bank systems contribute greatly to production batch consistency because the starting cell material is always the same. However, it may not be possible or feasible to create a cell bank, so appropriately tested and qualified primary cells may be used in lieu of creation of cell banks. The MCB and WCB should at a minimum be tested for identity, sterility, purity, viability, and the presence of viruses and mycoplasma.
